Pharming's C1 inhibitor product potentially effective in reducing complications following transplantation
(Thomson Reuters ONE) -
Leiden, The Netherlands, February 17, 2010. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today publication
of preclinical evidence that its recombinant human C1 inhibitor (rhC1INH) may
play an important therapeutic role in the prevention of delayed graft function
(DGF) after solid organ transplantation. The published study results further
indicate the potential for the product in the treatment of ischemia-reperfusion
injuries and in particular in the prevention of DGF following kidney
transplantation.
Pharming's rhC1INH significantly reduced several ischemia/reperfusion-related
inflammatory processes and significantly limited tissue damage in a swine model
of ischemia/reperfusion-induced renal damage. As the inflammatory processes in
pigs are very similar to those in humans, these results form a clear indication
of the potential of rhC1INH for treatment and prevention of ischemia tissue
damage in patients.
Ischemia/reperfusion injury is the major cause of DGF in transplanted kidneys.
DGF is an early sign associated with poor long-term graft function and survival.
Current treatments of DGF include the use of immune suppressing agents. Much
attention is also paid to prevention of DGF by continuous improvement of the
transplantation procedure itself and the conditions under which the organs or
tissues are stored and treated during the procedure. Because of its unique
anti-inflammatory properties Pharming's rhC1Inh may complement current
transplantation procedures and current treatment of DGF.
In October 2009, Pharming announced the beneficial results of another
preclinical study in the field of ischemia-reperfusion injuries, focussing on
the reduction of damage following brain infarcts (stroke). Several studies in
rodents indicate that the complement system plays a pivotal role in renal
ischemia reperfusion injury. To date, however, limited information was available
from humans and larger animals. This swine study has been supported by a
research grant from Pharming and was performed by researchers from the
University of Bari, Italy. The results are published in the American Journal of
Pathology Feb 2010; 176(4) by Dr Giuseppe Castellano and Professor Giuseppe
Grandaliano from the University of Bari.
Dr. Castellano commented: "DGF is an important medical problem. In the EU, each
year approximately 35,000 organs are transplanted. These procedures are costly
and patients often have to wait a long time before transplantation can be
performed. Further improvement of short-term and long-term outcomes will,
therefore, provide a valuable medical and economical benefit. The results of our
recent study are very promising in this regard."
Pharming's rhC1INH has Orphan Medicinal Product designation from the European
Medicines Agency for prevention of DGF after solid organ transplantation. This
status is granted to a product for which it is made plausible that it will have
a positive therapeutic effect on a disease or condition which is relatively rare
in the European Union and provides incentives for research, development and
marketing, in particular by granting exclusive marketing rights for a ten-year
period. Pharming intends to initiate a clinical study in patients at increased
risk for DGF later this year.
About transplantation
In the United States alone, over 79,000 patients are waiting for an organ
transplant (35,000 in the EU). Each month, nearly 3,000 new patients are added
to this waiting list. However, only 25,000 solid organs are available and
transplanted each year, including kidney, liver, lung and heart transplants. In
addition, complications may arise following organ transplantation, such as DGF
and Antibody Mediated Rejection (another complication of transplantation under
clinical investigation with Pharming's rhC1INH).
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, ageing diseases, specialty products for surgical indications, and
nutritional products. Pharming's lead product Rhucin® has completed clinical
development for acute attacks of Hereditary Angioedema and a Market
Authorization Application is under review with the EMA. Prodarsan® is in early
stage clinical development for Cockayne Syndrome and human lactoferrin for use
in food products The advanced technologies of the Company include innovative
platforms for the production of protein therapeutics, technology and processes
for the purification and formulation of these products, as well as technology in
the field of DNA repair (via DNage). Additional information is available on the
Pharming website, http://www.pharming.com.
This press release contains forward looking statements that involve known and
unknown risks, uncertainties and other factors, which may cause the actual
results, performance or achievements of the Company to be materially different
from the results, performance or achievements expressed or implied by these
forward looking statements.
Contact:
Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431 or +31 (0)6
109 299 54
Samir Singh, T: + 1 908 720 6224
[HUG#1385145]
Press release (PDF): http://hugin.info/132866/R/1385145/343855.pdf
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Datum: 17.02.2010 - 02:01 Uhr
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